Legal & Regulatory

Office of Prescription Drug Promotion finds little to complain about

'Average Manufacturer Price' is now a mostly settled matter

Industry is doing better at filing studies, but the agency is falling behind reviews, says GAO

Company partners with Teikoku for the latter's first marketed oncology product, and earns a milestone payment from Teva

'European companies will not be able to follow the exact path to operational compliance as their US counterparts,' says IMS Health survey

Quality control remains a problem among compounding pharmacies, but bigger players are entering the field

Promotional content produced for, or derived from, digital media presents its own management and compliance complexities

Thousands of poorly regulated websites are targeted

The growing number of certifications has become a competitive issue for SPPs bidding for Pharma's business

It's still early days in making medical marijuana--and cannabis-based pharmaceuticals--part of normal dispensing

Roughly 40% are for rare diseases; PD-1 oncolytics capture industry attention

GS1 Healthcare US publishes updated track-and-trace guidance; vendors revamp their offerings

Pharma companies will need to do more than rely on pharmacies' adjudication of claims

First to gain newly established program reviewing therapy management and chronic care

Securing your supply chain

How to prepare for reporting and utilizing published data for business and compliance purposes

Innovation award goes to Mem-O-Ring, a pill-bottle attachment

Mexico, Brazil and Chile will see new or expanded healthcare logistics capability

Pharma companies assess their ongoing reporting capabilities

AstraZeneca plots next moves

Getting to the 'future state' in cloud computing

Efforts of the National Biomarker Development Alliance will address the 'dismal' success rate of approved biomarker diagnostics

Companies are positioning themselves as approved high-volume compounders

New 'emergent biopharma' service combines compliance with pricing, market access

Long-awaited track-and-trace law ushers in a new era of pharmaceutical supply-chain monitoring; compounding pharmacies get a new structure also

The growing complexity of managed-markets contract support makes outsourcing a near-necessity for Small Pharma, and a better option for Big Pharma

Bill includes voluntary oversight by FDA of outsourced compounded pharmaceuticals, national distributor licensure, and a timetable for serialization and drug tracking